Obama Administration Overrules FDA on Availability of Plan B--Huge Slap in the Face to American Women
Oh no! Just as women's advocates were beginning to celebrate the FDA getting rid of restrictions for Plan B, or the one-pill emergency contraception, today--the move got blocked by none other than the Obama Administration's Health Secretary, Kathleen Sebelius. This was unexpected and shocking, and needless to say, disheartening. For teenagers, Plan B is extremely crucial--and the science backs this up.
in a rare public split among federal health officials, the Health and Human Services Department overruled a decision by the Food and Drug Administration to make the drug available to anyone of any age without a restriction.
In a statement, FDA Administrator Margaret A. Hamburg said she had decided the medication could be used safely by girls and women of all age. But she added that Health and Human Services Secretary Kathleen Sebelius had rejected the move.
“I agree ... there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” Hamburg said.
“However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential,” she said.
In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not “conclusively establish” that it could be used safely by girls of all ages....
The surprising decision is a stunning blow to some doctors, health advocates, family-planning activists, members of Congress and others to help women prevent unwanted pregnancies.
“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, a Washington-based advocacy group. “There is no rationale for this move. This is unprecedented as evidenced by the commissioner’s own letter. Unbelievable.”
This is an obviously political decision, and disappointingly anti-science. At RH Reality Jodi Jacobson calls this move "astounding," writing: "If we have been reminded of one thing in the past several months, it is that politicians and religious leaders alike will, when it suits them, marginalize the rights and needs of women to advance their own interests and need for power. And somewhere, someone in the Obama Administration, perhaps the president himself, gave the cue to HHS to overrule the FDA decision."
Today at GOOD, Amanda Hess compiled an oral history of Plan B use by prominent online feminists, who detailed their broken condom or failed sexual negotiation incidents over the past decade--as the FD was wrangling over Plan B--and the ensuing tears and prescriptions called in. These stories point out how important and vital the easy accessibility and lack of stigma around this drug is for American women's sexual health.